(152 days)
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use.
The proposed Disposable Nitrile Examination Gloves are ambidextrous, non-sterile, powder-free, and is made of nitrile (Acrylonitrile-butadiene copolymer) and chemical additives. It has a finger textured surface and is colored blue. This is a single use, disposable device(s), provided non-sterile.
The provided text describes the acceptance criteria and performance of "Disposable Nitrile Examination Gloves" (K210897) in comparison to a predicate device (K192333), as part of an FDA 510(k) summary.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria | Proposed Device Performance (Disposable Nitrile Examination Gloves - K210897) | Predicate Device Performance (Blue Nitrile Examination Gloves Powder Free - K192333) |
|---------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| Comparison |
| General Comparison | | | | |
| 510K Number | / | K210897 | K192333 | - |
| Product Code | LZA | LZA | LZA | Same |
| Classification | Class I (21 CFR 880.6250) | Class I (21 CFR 880.6250) | Class I (21 CFR 880.6250) | Same |
| Intended Use | A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner. The device is for over-the-counter use. | A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use. | A powder free patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Same |
| Material Use | Nitrile | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Blue | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| Performance Testing | | | | |
| Dimensions (ASTM D6319-19) | Overall Length (mm): 220 mm = (sizes XS-S), 230 mm = (sizes M-XL); Width (± 10 mm): Size S = 80 mm, Size M = 95 mm, Size L = 110 mm, Size XL = 120 mm; Thickness at Finger (mm): All Sizes = 0.05mm; Thickness at Palm (mm): All Sizes = 0.05mm | Length (mm): 220 mm = (sizes XS-S), 230 mm = (sizes M-XL); Width (± 10 mm): Size S = 80 mm, Size M = 95 mm, Size L = 110 mm, Size XL = 120 mm; Thickness-Finger (mm): All Sizes ≥ 0.05mm; Thickness-Palm (mm): All Sizes ≥ 0.05mm | Size: M, Length Min: 230mm, Palm Width Min: 95+/-10mm, Finger Thickness min: 0.05 mm, Palm Thickness min: 0.05 mm | Same |
| Tensile Strength (Before Aging ASTM D6319-19) | $\ge$ 14 MPa | > 14 min MPa | > 14 min MPa | Same |
| Ultimate Elongation (Before Aging) | $\ge$ 500% | 500 min % | 500 min % | Same |
| Tensile Strength (After Aging ASTM D6319-19) | $\ge$ 14 MPa | $\ge$ 14 min MPa | $\ge$ 14 min MPa | Same |
| Ultimate Elongation (After Aging) | $\ge$ 400% | 400 min % | 400 min % | Same |
| Freedom from Holes (ASTM D5151) | AQL 2.5 Inspection Level G-1 | Passes AQL-2.5 | Passes AQL-2.5 | Same |
| Residual Powder (ASTM D6124) | $\le$ 2.0 mg/pc | $\le$ 2.0 mg/pc | $\le$ 2.0 mg/pc | Same |
| Biocompatibility Testing | | | | |
| Primary Skin Irritation Test (ISO 10993-10) | Not an irritant | Under the conditions of the test, the test article would be considered a non-irritant. | Under the condition of study not an irritant. | Same |
| Dermal Sensitization Assay (ISO 10993-10) | Not a sensitizer | Under the conditions of this study, there is no evidence of skin sensitization in guinea pigs was found. | Under the conditions of the study not a sensitizer. | Same |
| Acute Systemic Test (ISO 10993-11) | No mortality or evidence of systemic toxicity | Under the conditions of this study, there is no mortality or evidence of systemic toxicity from the extracts. The test met the test requirements. | Under the condition of study the device extracts do not pose a systemic toxicity concern. | Same |
| Material Mediated Pyrogenicity (ISO 10993-11/USP 41) | No febrile reaction; meets requirements | Under the conditions of this study, the test article would be considered no febrile reaction. The test article meets the test requirements. | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. | Same |
| In Vitro Cytotoxicity (ISO 10993-5) | Not cytotoxic (or acceptable cytotoxicity with further testing/justification) | Under the conditions of this study, the MEM test extracts would be considered cytotoxic potential. | Under the conditions of the study, cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern. | Same |
| Intracutaneous Reactivity Test (ISO 10993-10) | Polar and non-polar extract score less 1.0; requirements met | The test result showed that the polar and non-polar extract of the final test sample score is less 1.0, the requirements of the test are met. | Not available. | N/A |
A key point is that for all tested Biocompatibility characteristics, the proposed device's performance aligns with the predicate device, with one notable difference for "In Vitro Cytotoxicity" where both devices were found to be cytotoxic, but the predicate device had "Additional testing was performed to determine if this was a systemic toxicity concern," implying the cytotoxicity might have been addressed or deemed acceptable in the predicate's clearance. The proposed device's statement "would be considered cytotoxic potential" suggests a similar outcome, and the "Same" comparison indicates this was consistent with the predicate.
The study that proves the device meets the acceptance criteria:
The study proving the device meets the acceptance criteria is a non-clinical test program that evaluates the "Disposable Nitrile Examination Gloves" against recognized industry standards and FDA guidance. This is explicitly stated in section 8: "The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Medical Glove Guidance Manual Document, issued on January 22, 2008."
The comparison tables (Table II - Performance Testing Comparison Table and Table III - Biocompatibility Testing Comparison Table) demonstrate that the proposed device's performance meets or exceeds the specified acceptance criteria and is substantially equivalent to the predicate device.
Absence of information for AI-specific questions:
The provided document is an FDA 510(k) summary for a medical device (disposable nitrile examination gloves). It does not pertain to an AI/ML-enabled medical device. Therefore, the following information is not applicable and not present in the document:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
The testing performed for this device relates to physical properties (dimensions, tensile strength, elongation, freedom from holes, residual powder) and biocompatibility (skin irritation, sensitization, systemic toxicity, pyrogenicity, cytotoxicity, intracutaneous reactivity), which are standard evaluations for such a product.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.